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Ongoing EU regulatory guideline changes for CTD module 1.6

By March 15, 2024March 18th, 2024No Comments

We are pleased to share the poster our colleague Arno Wess presented at EPHAR in 2021.

Title: “Ongoing EU regulatory guideline changes for CTD module 1.6 ”

On 15 November 2018 the European Medicines Agency has released a draft revision of the guideline on the environmental risk assessment (ERA) of medicinal products for human use (EMA 2018) for public consultation. The current guideline (EMEA 2006) describes a tiered testing strategy recommended for the evaluation process. In addition, there is a Questions and Answer (Q&A) document (EMA 2016). Commenting was possible until the 30 June 2019 (deadline for comments). This poster intends to summarize some of the most important changes in order to facilitate the preparation for expectable changes. An explaining commentary from authors working at various European authorities is available (Whomsley et al. 2019). It highlights mayor changes, whereat some are effectively already implemented based on the Q&A document (EMA 2016) or may differ more structurally such as the assessment for Persistence, Bioaccumulation and Toxicity (PBT), which is in the flow diagram placed as a process to be followed in parallel. Generally the structure of the assessment approach has been changed in that sediment toxicity testing will be a part of the standard aquatic base set testing, whereto the water/sediment simulation study (OECD TG 308) does not belong any more, but this test will probably often be triggered in the course of the new Phase II, Tier A groundwater assessment. Also soil organism effect testing is considered a Phase II, Tier A task, but its performance still depends on triggering, now (newly) based on a combination of adsorption and the initial Predicted Environmental Concentration (PEC) in surface waters. Also a secondary poisoning assessment for bioaccumulating substances is implemented for substances characterized by an BCF in fish of 100 L/kg or higher.